Research and development is the cornerstone of medical progress, but sometimes R&D turns into its evil twin brother, research and denial. Yesterday I reported on the the RESPECT (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment) trial presented at the TCT meeting in Miami. The trial missed its primary…
TCT: Two PFO Closure Trials Miss Primary Endpoints
October 25, 2012 by 1 Comment
Two trials presented today at the TCT meeting in Miami testing the benefits of PFO closure in patients with cryptogenic stroke have failed to convincingly demonstrate any significant benefit for the controversial procedure. The RESPECT (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment) trial randomized 980 patients to PFO closure…
Guest Post: New Questions Raised About Latest Generation St. Jude ICD Leads
August 21, 2012 by Leave a Comment
Editor’s Note: The following guest post is published with the permission of its author, Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. New Questions About Latest Generation ICD Leads From St. Jude by Edward J. Schloss A highly anticipated study analyzing failures of St. Jude Durata…
Guest Post: FDA Clarifies Riata Imaging Recommendations
August 17, 2012 by 1 Comment
Editor’s Note: The following guest post is published with the permission of its author, Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. Additional clarity regarding yesterday’s St. Jude Riata/Riata ST imaging recommendations has arrived in the form of another FDA Safety Communication available at the…
Guest Post: FDA Calls For X-Ray Screening Of Riata Leads And Additional Followup Studies
August 16, 2012 by 1 Comment
Editor’s Note: The following guest post is published with the permission of its author, Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. St. Jude’s troubled implantable defibrillator leads came under a fresh layer of scrutiny today with new FDA imaging recommendations and post-market study requirements. …
Guest Post: Shedding Light On Riata At The Heart Rhythm Society Meeting
May 10, 2012 by 2 Comments
Editor’s Note: The following guest post is published with the permission of its author, Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. Shedding Light On Riata At The Heart Rhythm Society Meeting by Edward J Schloss MD This morning in Boston, HRS 2012 sessions began with…
Heart Rhythm Editor Douglas Zipes Defends Peer Review
April 30, 2012 by 4 Comments
Rejecting an extraordinary request from industry to retract a controversial paper, Douglas Zipes, the editor-in-chief of HeartRhythm, has written a rare, highly pointed editorial defending the publication process. “If one disagrees with facts/statements in a publication,” writes the editor, Douglas Zipes, “there is a well-defined approach that can begin with a letter to the editor or submission…
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